Pharmaceutical manufacturers across the Globe are mandated to adopt Serialization and soon all products of pharmaceutical re-packagers / distributors must be serialized according to the Drug Supply Chain Security Act (DSCSA) by FDA. North America and Europe come first due to various gaps in the existing solutions and lack of exhaustive reporting, analytics and tracking capabilities. This raises a unique opportunity to include serialization capability to assign unique traceable numbers to individual items or units, as a separate line or as a part of existing packaging line. Need to have a full feature rich solution in line with GS1 standards to cater the Serialization mandates across the production site is the need of the hour.
An ecosystem approach to manufacturing is evolving in place of traditional supply chain
Standardization/harmonization of business processes and information systems is key
Multiple global regulatory standards and data integrity
A system that provides the capability to manage, enforce and document processes cross-company, replacing manual processes and paperwork with electronic workflows. It encompasses everything from routine operations to escalated responses to critical plant operating conditions.
Examples of electronic records include product and raw material specifications, bills of material, recipes, SOPs, laboratory instrument data, master production and batch records, equipment set up configurations and maintenance logs.
A system that can be used for the most complex batching processes which require a high level of flexibility. Built-in security and material management capabilities including material consumption, movements, and inventory levels contribute to a comprehensive Electronic Batch Record (EBR) and reduce the cost to comply with industry regulations.
Being a highly regulated industry, Life Sciences organizations are under constant scrutiny of the regulatory bodies about the data quality and data storage practices. Owing to the rise in violations and data issues in pharmaceutical manufacturing companies, regulators are focused on enforcing principles and practices keeping the interests of modern day patient in mind. Ability to access the collected, verified and validated data from multiple sources at any time helps Life Sciences organizations to not only respond to regulatory demands faster but also make use of the consolidated data to continually improve decisions.
Data Integrity Assessment and Remediation Approach
FDA-regulated companies are under intense scrutiny and data integrity enforcement actions are increasing due to recent violations. Ensuring data integrity is critical in both pre- and post-marketing approval activities. The Life Sciences industry must embark on data integrity programs and assess current systems and processes to build the infrastructure to comply with increasing regulations.
The Schneider Electric industrial software business and AVEVA have merged to trade as AVEVA Group plc, a UK listed company. The Schneider Electric and Life Is On trademarks are owned by Schneider Electric and are being licensed to AVEVA by Schneider Electric.